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NCT00441558 · ClinicalTrials.gov registry record · Phase 3
A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
A Phase 3 study, sponsored by Sprout Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,723
- Enrollment target
NCT00441558: Clinical Trial Phase 3 study, sponsored by Sprout Pharmaceuticals.
NCT00441558 is a Phase 3 study that was terminated before completion, run by Sprout Pharmaceuticals. The registered enrollment target is 1,723 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00441558, a Phase 3 study, was terminated before completion, sponsored by Sprout Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,723 participants
- Enrollment target
Study Summary
To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.
Primary Outcome
This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder
Interventions
- DRUG Flibanserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,723 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
Why NCT00441558 stopped before completion
NCT00441558 is an interventional study that assigns participants to a tested intervention. Its 1,723 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 1 intervention - of which Flibanserin is the first listed.
NCT00441558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00441558 about?
NCT00441558 is a clinical study titled "A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).". To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.
What is the current status of trial NCT00441558?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,723 participants. The study started on 2007-02. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00441558?
The interventions under investigation include: Flibanserin (DRUG).
Who is sponsoring clinical trial NCT00441558?
This trial is sponsored by Sprout Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00441558's enrollment target sits among peer trials
1,723 130th of 2000 higher than 1,871 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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